Device and method for screening congenital heart disease

ABSTRACT

An apparatus including a main processing unit. The apparatus further including a precordial patch coupled to the main processing unit, the precordial patch having a plurality of sensors for detecting heart sounds and cardiac electrical signals (ECG). The apparatus further including a probe coupled to the main processing unit, the probe having a sensor for detecting oxygen saturation of blood circulating through a human. A method is further described including simultaneously measuring and analyzing heart sounds, cardiac electrical signals (ECG) and oxygen saturation of blood circulating through a human. The method further includes performing an algorithm to determine the presence of a significant congenital heart disease and displaying management recommendations based on results of the algorithm.

Devices and methods for screening congenital heart disease. Inparticular, devices and methods for screening congenital heart diseasein newborns.

BACKGROUND

Congenital malformations are responsible for 40 percent (%) of neonatalmortality in term infants. Congenital heart disease (CHD) affects eightout of every 1000 live-born infants and accounts for the majority ofdeath due to congenital malformation in the first year of life. Manyinfants born with CHD are discharged from the hospital after birthwithout being diagnosed. Infants with undiagnosed CHD are at very highrisk for dying at home or returning to the emergency department withcardiovascular collapse. Such delayed CHD diagnosis and treatment oftenresults in life-threatening events and significant morbidities in theseinfants. Thus, early CHD diagnosis using screening techniques can belife-saving.

Clinical examination of the cardiovascular system at the time of routinenewborn examination has been practiced for more than 30 years. Currentguidelines recommend a routine clinical examination for all newborns atthe time of discharge and again at two weeks of age in thepediatrician's office. However, research studies have shown that morethan half of babies with CHD are missed by routine neonatal examination.Universal newborn screening for CHD has not been a part of routinepractice because of the lack of effective screening technology.

In view of these findings, researchers have searched for techniques toaid in detection of CHD. One technique currently used to screen for CHDis pulse oximetry. Pulse oximetry is a noninvasive technique whichallows a healthcare provider to monitor the percent of the patient'shemoglobin saturated with oxygen. Abnormal oxygen saturation may suggestthe presence of a CHD. A second technique used may be anelectrocardiogram (ECG). An ECG is a graphic or waveform produced by anelectrocardiograph machine which records the changes in electricalvoltage in the heart. However, each screening technique alone (pulseoximetry or ECG) has its limitations and potential for missingsignificant CHDs. Echocardiography has been considered for use in CHDscreening, however, due to the significant costs and personelrequirements associated with echocardiography, its use for universalscreening is impractical.

BRIEF DESCRIPTION OF THE DRAWINGS

The following illustration is by way of example and not by way oflimitation in the figures of the accompanying drawings m which likereferences indicate like elements. It should be noted that references to“an” or “one” embodiment in this disclosure are not necessarily to thesame embodiment, and such references mean at least one.

FIG. 1 shows a schematic drawing of one embodiment of an apparatusincluding a main processing unit and sensors for screening forcongenital heart disease.

FIG. 2 shows a schematic drawing of another embodiment of an apparatusincluding a main processing unit and sensors for screening forcongenital heart disease positioned on a newborn.

FIG. 3A shows a schematic drawing of one embodiment of a display screenof a main processing unit displaying congenital heart disease screeningresults.

FIG. 3B shows a schematic drawing of another embodiment of a displayscreen of a main processing unit displaying congenital heart diseasescreening results.

FIG. 3C shows a schematic drawing of another embodiment of a displayscreen of a main processing unit displaying congenital heart diseasescreening results.

FIG. 4 shows a flow chart of a method and algorithm for screening forcongenital heart disease in newborns.

DETAILED DESCRIPTION

A method and device for screening for heart disease are described. Inone aspect, the device and method may be used to screen for CHD innewborns. The term “newborn” generally refers to infants less than onemonth old. In this aspect, the device may be used to screen for CHD innewborns prior to discharge from a hospital nursery. It is furthercontemplated that the method and device described herein may be used toscreen for heart disease in children beyond the newborn period andadults. For example, the device may also be used in a pediatrician'soffice to examine toddlers with suspected heart murmurs. In addition,the device may be used for cardiac screening of young athletes and maypotentially pick up a significant number of heart diseases causingsudden death in athletes.

The device integrates techniques including pulse oximetry,electrocardiogram (ECG), and phonocardiogram into a main processing unitwith a built-in diagnostic algorithm and management recommendations forpractitioners. As will be described below, the integration of thesetechniques into a single device significantly improves detection of CHD.In one aspect, a precordial patch having a cable connected to the mainprocessing unit may be embedded with sensors for detecting heart soundsand electrical signals of the heart. A probe including a pulse oximetrysensor for detecting the oxygen saturation in the subject's blood mayfurther be connected to the main processing unit via a cable and placedupon the subject's toe. Data from each of these sensors may betransferred to the main processing unit through the respective cablesand analyzed using the diagnostic algorithm to determine the presence orabsence of CHD. The diagnostic results may further be used to determinemanagement recommendations for a healthcare professional. The managementrecommendations may be displayed on a display such as a liquid crystaldisplay (LCD) touch screen of the main processing unit to ensure thenewborn who has a positive screening receives a proper diagnosis andfollow up evaluations and/or treatment, if necessary. In this aspect,the device may include two cables and a simple display screen interfacesuch that it may require minimal personnel training to operate and insome embodiments, may take less than about five minutes to screen anewborn. The device may therefore be operated by, for example, nursesand/or nurse's assistants in a newborn nursery.

In one aspect, it is believed that an integrated device as describedherein will pick up the most significant and critical CHD of which thesymptoms and signs may not be apparent by clinical examination at thetime of hospital discharge but may manifest in the following two weeks.Although the device is not intended to replace the current practice ofnewborn examinations at hospital discharge, the device offers anadditional technique for screening critical heart disease in newbornsand provides important information so as to ensure that the newborn willnot become critically ill before he or she returns to the pediatrician'soffice at two weeks of life for a scheduled routine visit. It is furtherbelieved that the device will assist pediatricians in newbornexamination and decisions for nursery discharge.

FIG. 1 shows a schematic drawing of one embodiment of an apparatusincluding a main processing unit and sensors for screening for CHD. Inone embodiment, the apparatus is a device 100 having a main processingunit 102 for analyzing and displaying data indicating various heartactivities. In one embodiment, main processing unit 102 may be aportable computer or Pocket PC for signal processing such as thatcommercially available from Microsoft Corporation, Redmond, Wash. underthe model number HP iPAQ rx1955. Alternatively, main processing unit 102may be any computer suitable for signal processing, such as, a desktopor laptop computer. Main processing unit 102 may be programmed tointegrate and process data relating to various heart activitiesaccording to a predetermined diagnostic algorithm as will be describedbelow. Main processing unit 102 may further include capacity forinputting patient demographic data by keyboard or touch screen andmemory capability to store the data in hard drives or flash memorycards. Main processing unit 102 may also include capacity fortransferring data by wireless technology (such as infrared or Bluetooth)and printing of result summary to be pasted on medical record.

In one embodiment, a precordial patch 106 is connected to mainprocessing unit 102 by a cable 104. Precordial patch 106 may be made ofa flexible material including, but not limited to, a fabric, plastic orfoam. In one embodiment, precordial patch 106 has a dimension of fourinches by four inches, which corresponds to the size of a leftprecordium of a newborn who weighs between 2.5 and 4.5 kilograms. Thisis the birth weight range of over 95% of term newborns. The term“precordium” generally refers to a portion of the body including theanterior surface of the lower thorax. Alternatively, precordial patch106 may be of any size or dimension suitable for positioning precordialpatch 106 within a left precordium of a desired subject. For example,where precordial patch 106 is to be used on a child or adult having asize larger than a newborn, precordial patch 106 may have dimensionscorresponding to a left precordium of the child or adult.

In one embodiment, precordial patch 106 includes indicators foranatomical landmarks to ensure proper positioning of precordial patch106 on the subject. For example, in one embodiment, precordial patch 106includes a “cardiac apex” indicator 128, a “xiphoid process” indicator130 and a “sternal notch” indicator 132. Each indicator may be placedalong a surface of precordial patch 106 which may be viewed by anoperator of the device during use. Each indicator is positioned on aregion of precordial patch 106 which corresponds to a location withinthe left precordium the labeled region of precordial patch 106 is to bepositioned. For example, sternal notch indicator 132 may be positionedalong an upper medial border of precordial patch 106, xiphoid processindicator 130 may be positioned along a lower medial border ofprecordial patch 106 and cardiac apex indicator 128 may be positionedalong a lower lateral border of precordial patch 106. In this aspect, amedial border of precordial patch 106 is positioned between the sternalnotch and xiphoid process of the sternum.

In one embodiment, sensors for detecting cardiac electrical signals maybe secured to precordial patch 106. In one embodiment, the sensor may bean ECG sensor. The ECG sensors may be that which are commerciallyavailable from Welch Allyn Medical Products, Skaneateles Falls, N.Y. Inone embodiment illustrated in FIG. 1, a plurality of ECG sensors 108,110, 112, 114, 116 and 118 may be secured to precordial patch 106. ECGsensors 108, 110, 112, 114, 116 and 118 may be secured to precordialpatch 106 by embedding them within a material of precordial patch 106.Alternatively, any similarly suitable securing mechanism may be used tosecure ECG sensors 108, 110, 112, 114, 116 and 118 to precordial patch106, including, but not limited to, an adhesive or glue. ECG sensors108, 110, 112, 114, 116 and 118 may be wired inside precordial patch 106and bundled into cable 104 so as to electrically connect ECG sensors108, 110, 112, 114, 116 and 118 to main processing unit 102. Mainprocessing unit 102 may include a signal amplifier, filter and processorfor processing and analyzing signals received from ECG sensors 108, 110,112, 114, 116 and 118 for displaying ECG on a display screen.

In one embodiment, ECG sensors 108, 110, 112, 114, 116 and 118 may bepositioned on precordial patch 106 in the normal precordial leadpositions of V₁, V₂, V₃, V₄, V₅ and V₆ of a regular 12-lead ECG. Leads V1-V6 generally represent the electrical signals obtained from thehorizontal plane of the heart. In this aspect, when precordial patch 106is correctly positioned on, for example, a precordium of a newborn, ECGsensors 108, 110, 112, 114, 116 and 118 are properly positioned todetect electrical signals of the heart equivalent to leads V1-V6.Although six ECG sensors are shown in FIG. 1, it is further contemplatedthat any number of ECG sensors deemed desirable for detecting CHD may besecured to precordial patch 106. For example, in some embodiments, threeECG sensors may be secured to precordial patch 106. Alternatively,precordial patch 106 may include any number of ECG sensors capable offitting within the dimensions of precordial patch 106 and desired toachieve an accurate ECG reading. In one embodiment, ECG sensors 108,110, 112, 114, 116 and 118 may detect a signal in horizontal plane.Alternatively, a signal other than a horizontal plane (such as thefrontal plane) suitable for screening for congenital heart disease maybe detected by ECG sensors 108, 110, 112, 114, 116 and 118, andadditional ECG sensors (not shown in FIG. 1) for right arm (RA), leftarm (LA), right leg (RL) and left leg (LL) may be embedded in theprecordial patch 106 to obtain full 12-lead ECG. Representatively, suchadditional sensors for the arms and legs may be connected to (e.g.,embedded within) precordial patch 106 at the four comers of the patch,respectively. Alternatively, the sensors themselves may be separate fromthe patch but be wired inside precordial patch 106 and bundled intocable 104 (e.g., wires for the additional sensors extend on (e.g.,inside) precordial patch 106 and outside of the patch to allow thesensors to extend a desired length to, for example, the limbs of apatient).

In one embodiment, sensors for detecting heart sounds may be secured toprecordial patch 106. In one embodiment, the sensor may be aphonocardiogram sensor. Phonocardiogram sensors 120, 122 are tinymicrophones built into precordial patch 106 with high acousticsensitivity that picks up 20-20,000 Hertz (Hz) and circuit sensitivity10 millivolt/pascal (mV/Pa) +/−2.5 decibels (db). In one aspect, thephonocardiogram sensor may be that which is commercially available fromStethographics, Inc., Westborough, Mass. Still further, a plurality ofphonocardiogram sensors 120, 122 may be secured to precordial patch 106.Although two phonocardiogram sensors 120, 122 are illustrated in FIG. 1,it is further contemplated that any number of phonocardiogram sensorsdeemed desirable may be secured to precordial patch 106. Phonocardiogramsensors 120, 122 may be secured to precordial patch 106 by embeddingthem into a material of precordial patch 106. Alternatively, anysimilarly suitable securing mechanism may be used to securephonocardiogram sensors 120, 122 to precordial patch 106. Diaphragmssimilar to what are used in traditional stethoscopes may be mounted onthe sensors to improve acoustic sensitivity. Phonocardiogram sensors120, 122 may be wired inside precordial patch 106 and bundled into cable104 such that they are electrically connected to main processing unit102. Main processing unit 102 may include a processor for processing andanalyzing signals received from phonocardiogram sensors 120, 122 fordisplay on a display screen. During signal processing, the signals fromsensors 120, 122 may be amplified to increase signal amplitude andfiltered to reduce ambient noises. The phonocardiogram signals may bestored as digital sound files in the hard drive of the main processingunit 102.

Phonocardiogram sensors 120, 122 may be placed in the upper medial andlower medial comers of precordial patch 106 to pick up heart sounds fromthe upper sternal border and left lower sternal border of, for example,a newborn when properly positioned within a precordial region of thenewborn. Such positioning is deemed desirable as the upper sternalborder and left lower sternal border regions are typically the mostcommon places for significant heart murmurs in newborns. Alternatively,where other heart regions for murmurs are to be scanned, phonocardiogramsensors 120, 122 may be positioned on precordial patch 106 as desired.

In one embodiment, a sensor for detecting oxygen saturation of the bloodmay be secured to precordial patch 106. In one embodiment, the sensormay be a pulse oximetry sensor 126 electrically connected to mainprocessing unit 102 via cable 124. Main processing unit 102 may includea processor for processing and analyzing signals received from pulseoximetry sensor 126. Pulse oximetry sensor 126 may be a LNOP sensor,such as that commercially available from Masimo Corporation, Irvine,Calif. In one embodiment, pulse oximetry sensor 126 may be positioned onor within a probe 214 (see FIG. 2) suitable for holding pulse oximetrysensor 126 to, for example, a toe of a newborn. In this aspect, probe214 may be a fabric having an adhesive such that pulse oximetry sensor126 may be positioned on the toe and the fabric wrapped around the toeand adhered to itself to secure pulse oximetry sensor 126 to the toe.Alternatively, the probe may be a plastic clip having pulse oximetrysensor 126 within the clip designed for a toe inserted into the clip.Alternatively, pulse oximetry sensor 126 may be positioned adjacent toany other body region deemed suitable for screening for congenital heartdisease. In this aspect, the probe may be of any material and/ordimension deemed desirable for holding pulse oximetry sensor 126 to thedesired body region.

FIG. 2 shows a schematic drawing of another embodiment of an apparatusincluding a main processing unit and sensors for screening forcongenital heart disease positioned on a newborn. In this embodiment,precordial patch 106 is shown positioned along a precordial region of aninfant 200. Precordial patch 106 includes ECG sensors (not shown) andphonocardiogram sensors (not shown) as described in reference to FIG. 1.Precordial patch 106 is connected to main processing unit 102 via cable104 and is positioned on a precordial region of newborn 200 asillustrated in FIG. 2. Pulse oximetry sensor 126 is embedded withinprobe 214 and electrically connected to main processing unit 102 viacable 124. Probe 214 and pulse oximetry sensor 126 may be positioned ona toe 202 of infant 200 as shown.

In one aspect, a sterile sticker (not shown) may be applied to theprecordial region of the chest of newborn 200. The sticker may be of asubstantially similar dimension to that of a perimeter of precordialpatch 106. The sterile sticker may be disposable such that the stickeris designed for one time use only on each infant screened.Alternatively, the sticker may be of a reusable material which may becleaned between each use. In one embodiment, the sterile sticker may bemade of any material and of any dimension suitable for securingprecordial lead 106 to newborn 200 without interfering in thephonocardiogram and ECG reading. In one aspect, the material of thesticker may include, but is not limited to, a fabric, paper, plastic orother similarly suitable material. A gel may be applied to a side of thesticker to be placed upon newborn 200 to ensure excellent skin contactfor phonocardiogram and ECG transmission. Suitable gels may include, butare not limited to, a saline based electrode gel. A tight seal may beformed on an opposite side of the sticker adjacent a precordial patchside of the sticker. The seal may be formed by, for example, an adhesiveor glue applied between the sticker and precordial patch 106 surfaces.Precordial patch 106 and pulse oximetry sensor 126 may be cleaned aftereach use with a standard alcohol pad such that they may be reused fromone infant to the next.

Main processing unit 102 includes a display screen 204 for displayinginformation transmitted to main processing unit 102 from the ECG andphonocardiogram sensors of pericardial patch 106 and pulse oximetrysensor 126. In one embodiment display screen 204 may be a LCD or lightemitting diode (LED) display. In one embodiment, information from pulseoximetry sensor 126 may be displayed at a top 206 of display screen 204.Information from the phonocardiogram sensors may be displayed along amiddle 208 of display screen 204. Information from the ECG sensors maybe displayed at a bottom 210 of display screen 204. Alternatively,information from pulse oximetry sensor 126, phonocardiogram sensors andECG sensors may be displayed in any order and in any region of displayscreen 204 deemed desirable.

By viewing display screen 204, a care provider can monitor a patient'sheart activity and determine from the information displayed on displayscreen 204 whether the activity is normal (no CHD) or abnormal(potential CHD). For example, in one embodiment, an oxygen saturationlevel reading from pulse oximetry sensor 126 of less than 95% indicatesan abnormal reading. A sound or murmur reading by the phonocardiogramsensors beyond S1 and S2 indicates an abnormal reading. The terms “S1”(first heart sound) and “S2” (second heart sound) refer to the timing ofthe murmur with respect to a cardiac cycle. A systolic murmur, forexample, may occur between S1 and S2 and a diastolic murmur may occurbetween S2 and S1. Still further an ECG reading of an R wave greaterthan 27 millimeters in V 1 (right ventricular hypertrophy) or greaterthan 16 millimeters in V6 (left ventricular hypertrophy) indicates anabnormal reading. The phrase “R wave” generally refers to the initialpositive or upward deflection of the QRS complex in anelectrocardiogram. Further analysis of the ECG may be conducted tocompare with ECG norms of newborns (such as voltage amplitude,intervals, and cardiac rhythm). After screening results are displayed ondisplay screen 204, management recommendations for abnormal results maybe selected and displayed on a subsequent screen. The order of eachscreen display may be interactive (using touch screen) and in logicalsequence. Main processing unit 102 may further include a controlpanel212 including various buttons to allow the operator to, forexample, manually select settings of main processing unit 102.

FIG. 3A-3C show schematic drawings of embodiments of a display screen ofa main processing unit displaying congenital heart disease screeningresults. In FIG. 3A, a first screen 302 is illustrated which indicateswhether the overall results are normal 304 (in white) or abnormal 306(in black). About 95% to 98% of all newborns will have normal screens.The operator may exit screening at any time, such as where the resultsare normal, by clicking on “exit” button 314. Alternatively, if, forexample the results are abnormal, the operator may touch on a “resultdetails” button 308 or “recommendations” button 310 to go to a secondscreen 316 as illustrated in FIG. 3B (e.g., result details) or a thirdscreen 324 as illustrated in FIG. 3C (e.g., recommendations).

In one embodiment, second screen 316 may display result detailsincluding readings from the pulse oximetry sensor, phonocardiogramsensors and ECG sensors. Exemplary readings may be an oxygen saturationlevel 318, whether a murmur is detected 320 and whether right ventricleor left ventricle hypertrophy 322 is present. When the result detailsshow an abnormal reading (e.g. outside of a predetermined normal range),the care provider may touch on a “recommendations” button 310 of screen316 to go to third screen 324.

In one embodiment, third screen 324 may provide recommendations tailoredto the specific abnormalities detected. Exemplary recommendations mayinclude “Routine Discharge” 326, “Order Echocardiogram” 328, “CallPediatrician” 330, “Consult Cardiology” 332, “Consult Neonatology” 334and/or “Order 12-lead ECG” 336 depending upon the abnormality detected.Depending on the screening results from second screen 316, one or moreof the above recommendations will flash or be highlighted on thirdscreen 324 to indicate the recommended management.

In one embodiment, results displayed on each screen including cardiacscreening results, result details and recommendations may be stored in ahard drive (not shown) within the main processing unit 102 by clickingon a “save” button 312 of screen 302. Alternatively, the results may beautomatically stored to the hard drive at periodic intervals. In oneembodiment, the results may be transferred to a flash memory card (e.g.Secure Digital Memory Card) to be stored and/or analyzed on a computer.A built-in thermo-printer may further be provided to print a summary ofthe data. In this aspect, the results may be printed by clicking on“print” button 340 of screens 302, 316 or 324. The results may then beadded to the newborn's medical record, such as by pasting the resultsinto the record, for documentation and further evaluation. The operatormay exit screen 324 by clicking on “exit” button 314 of screen 324.

As shown in Table 1, device 100 can detect almost all critical andsignificant CHDs that one or two of the standalone testing technologiesmay detect as normal results. Device 100 can also screen for somearrhythmic disorders, such as congenital heart block and long QTsyndrome. Researchers have found links between long QT syndrome andsudden infant death syndrome. Early detection of long QT syndrome bydevice 100 may also help to prevent deaths from sudden infant deathsyndrome. The performance of the integrated system of the abovedescribed device 100 is assessed, as shown in Table 1, by itssensitivity in screening abnormal cardiac defects as it compares tostandalone technologies including pulse oximetry, ECG, andphonocardiograms. A list of the most common congenital cardiac defectswhich account for all critical CHDs and most (>95%) significant CHDs areused to compare the standalone technologies and device 100. Althoughsome CHDs could have normal pulse oximetry, or normal ECG, or normalphoncardiogram, it is extremely unlikely that a critical or significantCHD would have all three testing modalities as normal.

Table 1 illustrates screening results of the most common CHDs usingstandalone technologies and device 100 wherein a negative screen (−)indicates normal results and a positive screen (+) indicates abnormalresults.

Standalone Technology Integrated Technology Pulse Pulse Oximetry, ECG,Cardiac Diagnosis Oximetry ECG Phonocardiogram and PhonocardiogramNormal heart (−) (−) (−) (−) Coarctation of aorta (−) or (+) (−) or (+)(−) or (+) (+) Interrupted aortic arch (−) or (+) (−) or (+) (−) or (+)(+) HLHS (−) or (+) (−) or (+) (−) or (+) (+) Pulmonary Atresia (−) or(+) (−) or (+) (−) or (+) (+) d-TGA (−) or (+) (−) or (+) (−) or (+) (+)TAPVR (−) or (+) (−) or (+) (−) or (+) (+) Tricuspid Atresia (−) or (+)(−) or (+) (−) or (+) (+) Aortic Stenosis (−) (+) (+) (+) PulmonaryStenosis (−) or (+) (+) (+) (+) Truncus Arteriosus (−) or (+) (−) or (+)(−) or (+) (+) Ebstein's anomaly (−) or (+) (−) or (+) (−) or (+) (+)Tetralogy of Fallot (−) or (+) (−) or (+) (+) (+) VSD (−) (−) or (+) (+)(+) ASD (−) (−) or (+) (−) (−) or (+) PDA (−) (−) or (+) (−) or (+) (−)or (+) AV Canal (−) (−) or (+) (+) (+) Double Outlet RV (+) (+) (+) (+)Mitral Stenosis/ (−) or (+) (−) or (+) (−) or (+) (+) Shones complexCongenital heart block (−) (+) (−) (+) Long QT syndrome (−) (+) (−) (+)

In Table 1, HLHS represents hypoplastic left heart syndrome, d-TGArepresents d-transposition of great arteries; TAPVR represents totalanomalous pulmonary venous return, VSD represents ventricular septaldefect, ASD represents atrial septal defect and RV represents rightventricle; PDA represents patent ductus arteriosus.

The eight possible results based on normal or abnormal inputs from eachof the three testing modalities are illustrated in Table 2. Diagnosticalgorithms based on the flow chart shown in FIG. 4 may be performed todetermine whether confirmatory testing for CHD is necessary. Possibledifferential diagnoses for each of the eight possible results listed inTable 2 are considered and five management recommendations areillustrated in Table 3.

Table 2 illustrates eight possible results from the screening by device100 and management recommendations. A negative screen (−) indicatesnormal results and a positive screen (+) indicates abnormal results.

Integrated Possible Pulse Phonocar- Device 100 Management ResultsOximetry ECG diogram Reading Recommendation Result 1 (−) (−) (−) (−) IResult 2 (+) (−) (−) (+) II Result 3 (+) (+) (−) (+) II Result 4 (+) (−)(+) (+) II Result 5 (+) (+) (+) (+) II Result 6 (−) (+) (−) (+) IIIResult 7 (−) (+) (+) (+) IV Result 8 (−) (−) (+) (+) V

Management recommendations may be built into main processing unit 102 ofdevice 100 and screening results and recommendations may be displayed onthe display screen of main processing unit 102. In some embodiments, theresults may be printed on paper. In one embodiment, five possiblemanagement recommendations may be determined based on the eight possiblescreening results. Alternatively, any number of possible managementrecommendations may be determined based on the screening results.

Table 3 lists five possible management recommendations. These managementrecommendations can be further modified to fit the needs of differenthealth care environments.

I Normal oxygen saturation, normal ECG and no murmur - Normal screenreadings--- This is negative newborn screen, recommend discharge homewith routine pediatric follow up at 2 weeks of life. II Low pulseoximetry (<95%) with normal or abnormal ECG and phonocardiogram -probable cyanotic CHD, recommend immediate echocardiogram andinterpretation by qualified pediatric cardiac specialist prior todischarge. III Abnormal ECG, normal pulse oximetry and no murmur -Possible CHD, normal variant or artifact, recommend a fulll2-lead ECG.IV Abnormal ECG and phonocardiogram, normal oxygen saturation - ProbableCHD, recommend consulting a pediatric cardiac specialist, or immediateechocardiogram. V Cardiac murmur, normal ECG and normal oxygensaturation - Possible CHD, closing patent ductus or innocent murmur,recommend examination by a pediatrician or consulting a pediatriccardiac specialist

FIG. 4 shows a flow chart of a method for screening for congenital heartdisease in newborns. As previously discussed, diagnostic algorithms foranalyzing data from the sensors may be based on flow chart 400. Thediagnostic algorithms shown in FIG. 4 can be further modified to fit theneeds of different health care environments. In one embodiment, anewborn is screened for CHD prior to being discharged from the hospital(block 402). Alternatively, where device 100 is used in a follow upappointment or on a child or adult, screening may occur after hospitaldischarge. Precordial patch 106 and pulse oximetry sensor 126 may beproperly positioned on the newborn as previously described. Each of thesensors completes a reading (blocks 404, 410, 414) and the informationis transferred to main processing unit 102 and displayed on displayscreen 204. In some cases, the readings may be completed in less thanfive minutes.

Subsequent screening and/or confirmatory tests and managementrecommendations may be determined from the readings using the diagnosticalgorithm as follows. In one embodiment, a pulse oximetry reading (block404) less than 95% indicates a probable cyanotic CHD (block 408) andtherefore further tests may be recommended. The term “cyanotic”generally refers to a bluish discoloration of the skin and mucousmembranes due to decreased oxygen saturation in the blood. In thisaspect, the operator may select recommendations screen 324 of device 100to determine what additional tests, if any, should be performed. In oneembodiment, the management recommendation may be an echocardiogram(block 412). The echocardiogram may be performed and then interpreted bya qualified pediatric cardiac specialist prior to discharge of thenewborn to determine whether the newborn has cyanotic CHD (abnormal)(block 416) or no cyanotic CHD (normal) (block 418). If it is determinedthat the newborn has cyanotic CHD (block 416), a cardiologist may becalled to examine the newborn and decide if further treatment is neededprior to discharge. Alternatively, if no cyanotic CHD (block 418) isdetected, the newborn may be transferred to a neonatal intensive careunit (NICU) for further monitoring and evaluation (block 420).Representatively, cyanotic CHD conditions requiring further confirmatorytests may include, but are not limited to, hypoplastic left heart,tricuspid atresia, pulmonary stenosis, pulmonary atresia, transpositionof great arteries, tetralogy of fallout, truncus arteriosus, totalanomalous pulmonary venous return (TAPVR), coarctation of aorta,interrupted aortic arch, Ebstein's anomaly, double outlet rightventricle (RV), single ventricle and complex CHD (block 416). Cyanosisfrom non-cardiac causes (no cyanotic CHD) may include transienttachypnea of the newborn (TTN), persistent fetal circulation (persistentpulmonary hypertension), pneumothorax, pneumonia, other pulmonaryetiology and artifact (block 418).

In one embodiment, a pulse oximetry reading greater than 95% mayindicate a normal heart, non-cyanotic CHD or overcirculated “cyanotic”CHD (block 406) and therefore further tests may be recommended. In oneaspect, a phonocardiogram reading (block 410) and ECG reading (block414), for example, a 6-lead ECG reading, are further considered todetermine if the reading is abnormal or normal. In one embodiment, aphonocardiogram reading indicating a murmur results in a recommendationof a clinical exam by a pediatrician or cardiologist (block 422). Wherethe physician determines there is a possibility that the murmur may becaused by a pathological condition, an echocardiogram of the newborn isrecommended (block 424). Where a normal echocardiogram result isdetermined, the suspicion of CHD is eliminated (block 426) and thenewborn may be safely discharged (block 428). Alternatively, where anabnormal echocardiogram result is determined, the newborn may bediagnosed as having a non-cyanotic CHD or a cyanotic CHD (block 430) andfurther confirmatory tests and/or treatment are recommended.Representatively, conditions requiring further confirmatory tests mayinclude cyanotic CHD conditions (block 416) as well as non-cyanotic CHDconditions including, but not limited to, ventricular septal defect(VSD), aortic stenosis, pulmonary stenosis, supravalvar stenosis,atrioventricular (AV) canal, atrial septal defect (ASD) and patentductus arteriosus (PDA) (block 430).

In one embodiment, where the oximetry reading (block 404) is greaterthan 95%, a phonocardiogram reading (block 410) is normal and a 6-leadECG reading (block 414) is normal, the diagnosis is no suspicion of CHD(block 426) and the newborn may be safely discharged (block 428).

Alternatively, in the case of a pulse oximetry reading greater than 95%a phonocardiogram reading (block 410) that is normal and a 6-lead ECGreading (block 414) which is abnormal, a 12-lead ECG reading may berecommended (block 432) to further evaluate the newborn. Where the12-lead ECG reading is normal, there is no suspicion of CHD (block 426)and the newborn may be safely discharged (block 428). Alternatively,where the 12-lead ECG reading is determined to be abnormal, it isrecommended that a cardiologist is consulted (block 434). Thecardiologist may then evaluate the results thus far to determine whetherthe results are normal or abnormal. If the cardiologist determines theresults are normal and the diagnosis is that there is no suspicion ofCHD (block 426), the newborn (block 428) may be discharged.Alternatively, where the cardiologist determines the results areabnormal, a cyanotic or non-cyanotic CHD (blocks 430, 416) or anarrhythmia associated condition including, but not limited to, completeheart block, bradycardia, tachycardia, atrial flutter and long QTsyndrome, may be diagnosed and further evaluation and/or treatmentrecommended.

In some embodiments, device 100 may include an adjustable screeninglevel. Healthcare environment differs significantly among urban,suburban and rural hospitals therefore availability of echocardiography,cardiac specialists and follow up appointment may be entered intoconsiderations in the CHD screening algorithm. High screeningsensitivity may yield high pick up rate of CHDs, but the rate of falsepositive results may also increase. In one aspect, high sensitivity maybe more useful in areas where follow up may be difficult due togeographic or social reasons. Alternatively, low sensitivity may resultin fewer false positive cases (high specificity). In this aspect, lowsensitivity may be used to screen the most critical and significant CHDand may be more useful in areas with good follow up arrangement. Device100 may have algorithms for different levels of screening sensitivityand allow users to adjust the level of sensitivity for screening. Thisadjustable sensitivity feature allows users from various healthcareenvironments to customize their needs for newborn CHD screening.

In the preceding detailed description, specific embodiments aredescribed. It will, however, be evident that various modifications andchanges may be made thereto without departing from the broader spiritand scope of the claims. The specification and drawings are,accordingly, to be regarded in an illustrative rather than restrictivesense.

1-20. (canceled)
 21. A method for detecting congenital heart diseasebased on a triple screen facilitated by an apparatus comprising aprecordial patch configured to be secured to a newborn human subject,the precordial patch comprising dimensions for positioning theprecordial patch within a precordium of a newborn human subject, themethod comprising: receiving first information associated with adetected oxygen saturation, the first information being received from aplurality of first sensors associated with the precordial patch;receiving second information associated with a presence or absence of adetected heart murmur and/or a detected cyanotic heart defect, thesecond information being received from a plurality of second sensorsdisposed at the precordial patch; receiving third information associatedwith a presence or absence of detected abnormal electrical activity of aheart, the third information being received from a plurality of thirdsensors disposed at the precordial patch; and facilitating adetermination of a presence of congenital heart disease based on allthree of (1) the detected oxygen saturation, (2) the presence or absenceof a detected heart murmur and/or a detected cyanotic heart defect, and(3) the presence or absence of detected abnormal electrical activity ofa heart.
 22. The method of claim 21, wherein a given first sensor isconfigured to facilitate detecting oxygen saturation based on pulseoximetry.
 23. The method of claim 21, wherein a given second sensor isconfigured to facilitate one or both of detecting heart murmur based ona phonocardiogram or detecting cyanotic heart defect based on anechocardiogram.
 24. The method of claim 21, wherein a given third sensoris configured to facilitate detecting abnormal electrical activity of aheart based on an electrocardiogram.
 25. The method of claim 21, whereinthe determination of the presence of congenital heart disease isperformed by one or more processing units disposed at the precordialpatch.
 26. The method of claim 21, wherein the determination of thepresence of congenital heart disease is performed by one or moreprocessing units disposed separately from the precordial patch andconfigured to be communicatively coupled with the precordial patch. 27.The method of claim 21, further comprising facilitating display of anoutcome of the determination of the presence of congenital heart. 28.The method of claim 21, wherein the plurality of second sensors isdisposed at a different region of the precordial patch than theplurality of third sensors.
 29. The method of claim 21, furthercomprising determining a management recommendation based on thedetermination of the presence of congenital heart disease.
 30. Themethod of claim 21, further comprising modifying a sensitivity of thedetermination of the presence of congenital heart disease.
 31. Anapparatus configured for detecting congenital heart disease based on atriple screen, the apparatus comprising: a precordial patch comprisingdimensions for positioning the precordial patch within a precordium of anewborn human subject; a plurality of first sensors associated with theprecordial patch, a given first sensor being configured to facilitatedetecting oxygen saturation based on pulse oximetry; a plurality ofsecond sensors disposed at the precordial patch, a given second sensorbeing configured to facilitate one or both of (1) detecting heart murmurbased on a phonocardiogram or (2) detecting cyanotic heart defect basedon an echocardiogram; a plurality of third sensors disposed at theprecordial patch, a given third sensor being configured to facilitatedetecting abnormal electrical activity of a heart based on anelectrocardiogram; and one or more processing units configured todetermine a presence of congenital heart disease based on all three of(1) a detected oxygen saturation, (2) a presence or absence of adetected heart murmur and/or a detected cyanotic heart defect, and (3) apresence or absence of detected abnormal electrical activity of a heart.32. The apparatus of claim 31, wherein the one or more processing unitsare disposed at the precordial patch.
 33. The apparatus of claim 31,wherein the one or more processing units are disposed separately fromthe precordial patch and are configured to be communicatively coupledwith the precordial patch.
 34. The apparatus of claim 31, furthercomprising a display configured to present an outcome of thedetermination of the presence of congenital heart.
 35. The apparatus ofclaim 34, wherein the display is disposed at the precordial patch. 36.The apparatus of claim 34, wherein the display is disposed separatelyfrom the precordial patch.
 37. The apparatus of claim 31, wherein theplurality of second sensors is disposed at a different region of theprecordial patch than the plurality of third sensors.
 38. The apparatusof claim 31, wherein the one or more processing units are furtherconfigured to determine a management recommendation based on thedetermination of the presence of congenital heart disease.
 39. Theapparatus of claim 31, wherein the one or more processing units arefurther configured to modify a sensitivity of the determination of thepresence of congenital heart disease.
 40. The apparatus of claim 31,wherein the patch further comprises at least one indicator for ananatomical landmark.